Change Management in Laboratories / Quality Organizations

BSM lead large, transformative change initiatives on sites across the world in the pharmaceutical and life sciences sectors. Management of such initiatives is not trivial and can indeed be quite difficult, but the benefits that can be realized constitute a marked improvement on the status quo. Over the past decade, BSM have developed detailed and structured methodologies to ensure that change is implemented smoothly and, most importantly, that it is sustained into the future.

The goals of change management in pharmaceutical and life science settings are no different to those in any other organization. Put simply, the goal is the realization of a future state that is an advancement of a former one. In more complex terms, the goals involve the design, implementation, measurement and sustainment of a change initiative, whilst also enhancing the on-going or future capacity for the organization to manage change.

Change within the pharmaceutical and life science sectors is by no means a new phenomenon. However, it appears that of late there has been an increase in both the number and the pace of such change programs. Several factors are contributing to this, including:

1. Development and release of new technologies in favour of more traditional methods,
2. Competition (intra- and inter-company, regionally and globally) and
3. Economic factors – the global economic downturn has forced organizations to focus on cost saving / productivity improvement initiatives.

BSM Real Lean solutions involve large transformative changes, and routinely such projects are multi-site endeavours across a client’s global organization to ensure a standard approach. Independent research estimates that a staggering 60-70% of all global change programs fail. Interesting, changing mindsets and attitudes is often identified as the reason for failure. In the early stages of a change initiative there can be great resistance to the proposed change. In many cases, there is not necessarily a disagreement with the benefits of the new process, but rather a fear of the unknown future state and how it will work in real, practical terms. If a project is to succeed the team managing the change needs to:

1. inform/communicate with people at all levels early and at all stages of a project,
2. involve them in the process creating ownership and fostering belief in the new system(s), and
3. clearly demonstrate to everyone there is a real need for change to occur. Doing this will allay the fears of the ‘on the fence’ majority and thus ensure that the design and implementation phases run more smoothly, and of course will also impact the probability that the change can be sustained far into the future.

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• Creating the overlap between externally led change and internally led change (often if a change initiative is perceived as being entirely externally driven, there can be greater resistance to the change)
• Motivating teams, explaining the need/reason for change (explaining the expected outcomes and benefits of the future regimen for the individual, group (e.g. lab) and organization (e.g. plant)
• Generating ownership with the creation of local project teams that are involved in all stages of the design and implementation of the solutions/future states
• Having very detailed deliverables/milestones to be realized throughout the project and meeting regularly with project teams and management support groups to review the progress of same ensuring adherence to timelines
• Sharing the vision/roadmap at all stages of the project with all parties (i.e. people at all levels of the organization and other departments that interact with the department undergoing the change - communication, communication, communication!

In summary, successful change management programs need to address the ‘people’ aspect of the change as well as the ‘system’ facets in order to effect real change that is sustainable into the future. Change has impact for individuals (behaviours), groups (e.g. lab group, culture) and the organization (groups are but links in a chain and knock-on effects must be considered and addressed). To not change is to stagnate, and in the current climate change is inevitable! It should be embraced and thought of as a positive opportunity with which to improve operations. Any change management program/plan must be deliberate and structured to avoid failure with clear reasoning behind the change from current to future state, roadmap/deliverables against timelines and must involve strong sponsorship to see them through on target and avoid any regression. All of the above need to be underpinned by comprehensive communication to all parties throughout the entire process.